The University of Rochester Clinical Trials Unit (UR CTU) proposes to conduct HIV/AIDS clinical research with two NIAID HIV/AIDS Clinical Research Networks, 1) the 'Adult HIV Therapeutic Strategies Network' (AHTSN) and 2) the 'Vaccines to Prevent HIV Infection Network' (VPHIN). The CTU will consist of 3 Clinical Research Sites (CRS), two of which will be operated by the 'Infectious Diseases Division' in the Department of Medicine at the University of Rochester; one conducting therapeutic research for the 'AHTSN' and the other conducting vaccine prevention research for the 'VPHIN'. The third CRS will be located at the Baylor College of Medicine (BCM) 'Vaccine Research Center' in the Department of Molecular Virology and Microbiology in Houston, TX and will conduct research for the 'VPHIN'. The CRS conducting therapeutic research for the 'AHTSN' at UR will include collaborating investigators from the University of Buffalo, and AIDS Care, Inc. The CRS conducting vaccine prevention research at BCM will include collaborating investigators from the University of Texas Health Science Center at Houston. The specific aims of the CTU will be to: 1) Establish and integrate outstanding Clinical Research Sites that conduct clinical trials under the two NIAID Clinical Research Networks (the 'AHTSN' and 'VPHIN') to effectively advance NIAID HIV/AIDS clinical research activities; 2) Provide outstanding scientific, administrative and fiscal leadership that is responsive to the NIAID and 'AHTSN' and 'VPHIN' leadership groups to advance and enhance NIAID HIV/AIDS clinical research activities, and to conduct a continuous evaluation process that optimizes performance of such activities, 3) Provide outstanding infrastructure (including laboratory, pharmacy, regulatory compliance, data management, quality management and staff training) that effectively supports NIAID HIV/AIDS clinical research activities at the UR and BCM, and 4) Stimulate communication and engagement with the full range of communities that the CTU serves, and to promote robust community participation in NIAID HIV/AIDS clinical research activities, which includes the support of well-integrated Community Advisory Boards and community education programs in Rochester and Houston. RELEVANCE: The UR CTU will conduct rigorous, high-quality, cost-effective ethical clinical research designed to improve public health by contributing to the establishment of standards-of-care for medical conditions affecting people living with HIV (under the leadership of the NIAID 'Adult HIV Therapeutic Strategies Network') and the development of a safe and effective preventive HIV vaccine (under the leadership of the NIAID 'Vaccines to Prevent HIV Infection Network').